Beipackzettel - Aripiprazol Ascend 30 mg Tabletten
Zusammenfassung des Risikomanagement-Plans gemäß § 34
Public Summary of the Risk Management Plan according to Section 34 Sentence 1a sub-section 3 of the
Medicinal Products Act(2)
Aripiprazol Ascend 10 mg Tabletten
Aripiprazol Ascend 15 mg Tabletten
Aripiprazol Ascend 30 mg Tabletten
Administrative Information:
| Wirkstoff | Aripiprazol |
| ATC-Code | N05AX12 |
| Darreichungsform | Tablette |
| Art der Anwendung | zum Einnehmen |
| Inhaber der Zulassung | Ascend GmbH Sebastian-Kneipp-Straße 41 60439 Frankfurt am Main Deutschland |
| Zulassungsnummern | 7004049.00.00 7004050.00.00 7004051.00.00 |
| Datum der Zulassung | 17.02.2023 |
| Verkaufsabgrenzung | verschreibungspflichtig |
| Version und Datum des Risikomanagement-Plans | 0.1 / 20.01.2021 |
| Datum der Genehmigung des RMPs | 17.02.2023 |
Der im Folgenden wiedergegebene Ausschnitt des Risikomanagement-Plans (RMP) der o. g. Arzneimittel ist eine Zusammenfassung der wesentlichen Inhalte des RMP. Der RMP beschreibt die zu ergreifenden Maßnahmen zur Arzneimittelsicherheit, die Aktivitäten im Risikomanagement und in der Risikoanalyse um sicherzustellen, dass diese Arzneimittel so sicher wie möglich angewendet werden.
Weitere Informationen zu RMP-Zusammenfassungen finden Sie(nur auf Englisch verfügbar).
Diese RMP-Zusammenfassung sollte in Verbindung mit der Zusammenfassung des öffentlichen Bewertungsberichts und der Produktinformation zu o. g. Arzneimitteln gelesen werden, welche Sie auf der Produktseite auf PharmNet.Bundfinden können.
Diese Zusammenfassung des RMPs wurde durch das Bundesinstitut für Arzneimittel und Medizinprodukte am 19. April 2023 veröffentlicht.
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PART VI: SUMMARY OF THE RISK MANAGEMENT PLAN
Summary of risk management plan for Aripiprazole 5 mg, 10 mg, 15 mg and 30 mg tablets
This is a summary of the risk management plan (RMP) for Aripiprazole 5 mg, 10 mg, 15 mg and 30 mg tablets. The RMP details important risks of Aripiprazole 5 mg, 10 mg, 15 mg and 30 mg tablets, how these risks can be minimised, and how more information will be obtained about Aripiprazole 5 mg, 10 mg, 15 mg and 30 mg tablet’s risks and uncertainties (missing information).
Aripiprazole 5 mg, 10 mg, 15 mg and 30 mg tablet’s summary of product characteristics (SmPC) and its package leaflet give essential information to healthcare professionals and patients on how Aripiprazole 5 mg, 10 mg, 15 mg and 30 mg tablets should be used.
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I. The medicine and what it is used for
Aripiprazole 5 mg, 10 mg, 15 mg and 30 mg tablets are authorised for treatment of schizophrenia and moderate to severe manic episodes in Bipolar I Disorder (see SmPC for the full indication). It contains aripiprazole as the active substance and it is given by oral route.
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II. Risks associated with the medicine and activities to minimise or further characterise the risks
Important risks of Aripiprazole 5 mg, 10 mg, 15 mg and 30 mg tablets, together with measures to minimize such risks, are outlined below.
Measures to minimise the risks identified for Aripiprazole 5 mg, 10 mg, 15 mg and 30 mg tablets:
- Specific information, including warnings, precautions, and advice on correct use, in the package leaflet and SmPC addressed to patients and healthcare professionals;
- Prescription only medicine.
Together, these measures will constitute routine risk minimisation measures.
In addition to these measures, information about adverse reactions is collected continuously and regularly analysed, so that immediate action can be taken as necessary. These measures constitute routine pharmacovigilance activities.
The important information that may affect the safe use of Aripiprazole 5 mg, 10 mg, 15 mg and 30 mg tablets is not yet available, it is listed under ‘missing information’ below
EU RMP Version 0.1
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II.A List of important risks and missing information:
Important risks of Aripiprazole 5 mg, 10 mg, 15 mg and 30 mg tablets are risks that need special risk management activities to further investigate or minimise the risk, so that the medicinal product can be safely taken. Important risks can be regarded as identified or potential. Identified risks are concerns for which there is sufficient proof of a link with the use of Aripiprazole 5 mg, 10 mg, 15 mg and 30 mg tablets. Potential risks are concerns for which an association with the use of this medicine is possible based on available data, but this association has not been established yet and needs further evaluation. Missing information refers to information on the safety of the medicinal product that is currently missing and needs to be collected (e.g. on the long-term use of the medicine);
| Important identified risks |
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| Important potential risk |
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| Missing information |
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II.B Summary of important risks
The safety information in the proposed Product Information is aligned to the reference medicinal product.
II.C Post-authorisation development plan
II.C.1 Studies which are conditions of the marketing authorisation
There are no studies which are conditions of the marketing authorisation or specific obligation of Aripiprazole 5 mg, 10 mg, 15 mg and 30 mg tablets.
II.C.2 Other studies in post-authorisation development plan
There are no studies required for Aripiprazole 5 mg, 10 mg, 15 mg and 30 mg tablets.
Ascend GmbH
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Confidential